CLASS II Device recall · Reported 16 Jan 2013 · FDA Enforcement Report

Sterile Rigid Tip Suction Wand The Suction Wands recalled

California Medical Laboratories is recalling Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess, distributed in Arizona, California, Colorado, Florida, Louisiana, Mississippi. The recall was initiated on 2 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No: SU-12202 Lot No: S112462, S111480

Quantity recalledS112462=995 units & S111480 1430 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0649-2013
FDA event ID: 63896
Recalling firm: California Medical Laboratories, Costa Mesa, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2012
FDA classified: 7 Jan 2013
Reported: 16 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

2 Nov 2012	Recall initiated by company
7 Jan 2013	Classified by FDA	+66 days
16 Jan 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

Product as listed by the FDA

Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.

Where it was distributed

Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.

Arizona California Colorado Florida Louisiana Mississippi

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog No: SU-12202 Lot No: S112462, S111480

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 63896

Reported	Class	Recall	Company	Reason	Where
16 Jan 2013	CLASS II	Rigid Tip Suction Wand Non sterile bulk devices (S112468N recalled	California Medical Laboratories	Other	6 states

More recalls from California Medical Laboratories

All 2

Reported	Class	Recall	Company	Reason	Where
16 Jan 2013Device	CLASS II	Rigid Tip Suction Wand Non sterile bulk devices (S112468N recalled	California Medical Laboratories	Other	6 states

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